The Prevalence of Pulmonary Hypertension in Patients With COVID-19.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04459364|
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
The virus infection Covid-19 fills our hospitals and intensive care departments in a very unique way and there is a lack of essential insight into the pathophysiology of the disease. As a result, very specific treatment options are missing. The US Medicines Agency (FDA) has in the last days given a general license for treatment with inhaled nitric oxide (iNO). Inhaled NO in Sweden (and Europe) is approved for the indication of pulmonary hypertension in adults.
However, no one has yet described the occurrence of pulmonary hypertension, with or without right ventricular loading, in the Covid-19 patients who become so seriously ill that they need to be treated at an IVA ward. Knowledge of this is, of course, a prerequisite for determining the need for pulmonary artery catheterization (PA catheter, Swan-Ganz catheter) and also to better understand whether iNO treatment or other forms of lung selective vasodilation therapy may be of benefit to this patient group.
|Condition or disease|
|Hypertension, Pulmonary Right Ventricular Overload COVID|
Demographics and data from study variables will be documented in paper CRFs at the investigational site.
o Age, sex
Covid-19 related variables
o COVID-19 diagnosis
o Comorbidity, previous and present
Cardiovascular risk factors
- Laboratory values
- On-site measurements o Evaluation with echocardiography
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||80 participants|
|Target Follow-Up Duration:||21 Days|
|Official Title:||The Prevalence of Pulmonary Hypertension, With or Without Right Ventricular Loading, in Patients With COVID-19 Who Are Being Treated With a Respirator in the Intensive Care Unit.|
|Actual Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||July 7, 2020|
|Estimated Study Completion Date :||July 10, 2020|
- Prevalence [ Time Frame: Day 1 ]To determine the prevalence of pulmonary hypertension and right ventricular load in patients with COVID-19 treated in intensive care unit evaluated by routine echocardiography.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04459364
|Contact: Per-Arne Lönnqvist, Professorfirstname.lastname@example.org|
|Karolinska University Hospital||Recruiting|
|Stockholm, Sweden, 17176|
|Contact: Per-Arne Lönnqvist, Professor +46707210650 email@example.com|
|Principal Investigator:||Per-Arne Lönnqvist, Professor||Karolinska Institutet|